Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Lymphoma

Lymphoma, Mantle-Cell

Graft vs Host Disease

Leukemia, Mast-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Hematologic Diseases

Mastocytosis

Mastocytosis, Systemic

Mast Cell Activation Disorders

Chronic Graft Versus Host Disease

Lymphosarcoma

Mantle Cell Lymphoma

Homologous Wasting Disease

Acute Graft Versus Host Disease

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antipyretics

Analgesics

Antineoplastic Agents

Antirheumatic Agents

Anti-Infective Agents

Dermatologic Agents

Neuroprotective Agents

Anti-Allergic Agents

Central Nervous System Depressants

Emetics

Other Dietary Supplements

Granisetron

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Acetaminophen

Rituximab

Cyclosporine

Cyclosporins

Prednisolone

Lenograstim

Mycophenolic Acid

Thymoglobulin

Glucocorticoids

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Diphenhydramine

Promethazine

Benzocaine

Antilymphocyte Serum

Antineoplastic Agents, Immunological

Immunologic Factors

Adjuvants, Immunologic

Enzyme Inhibitors

Immunosuppressive Agents

Clotrimazole

Miconazole

Antifungal Agents

Calcineurin Inhibitors

Analgesics, Non-Narcotic

Hormones

Hormone Antagonists

Protective Agents

Antineoplastic Agents, Hormonal

Hypnotics and Sedatives

Anesthetics

Anesthetics, Local

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

Serotonin

Serotonin 5-HT3 Receptor Antagonists

Tannic Acid

Rituximab will be infused after a non-myeloablative transplantation regimen of total lymphoid irradiation (TLI) + anti-thymoglobulin (ATG), with the intention of reducing chronic graft-vs-host disease (cGvHD)

Total lymphoid irradiation (TLI) administered at 80cGy for 10 days

Total lymphoid irradiation

Rituximab 375 mg/m2 administered as an intravenous (IV) infusion once weekly for 4 doses.

Rabbit anti-thymoglobulin (ATG) administered from Day -11 through Day -7 (5 doses) at 1.5 mg/kg/day, for a total dose of 7.5 mg/kg.

Anti-thymoglobulin, rabbit (ATG, rabbit ATG)

Cyclosporine (CSP) administered orally at 6.25 mg/kg twice-a-day (BID) from Day -3 until through Day +56 post-peripheral blood progenitor cell (PBPC) infusion. Dose may be adjusted to maintain a therapeutic level of cyclosporine, or in response to renal insufficiency. If at Day +56, chimerism assessment demonstrates \> 40% donor cells in the CD3+ lineage, and the patient is without evidence of GvHD, then cyclosporine taper will begin (6% reduction per week).

Mycophenylate mofetil (MMF) will be administered at 15 mg/kg po Day 0, at 5 to 10 hours after mobilized PBPC infusion is complete

Mycophenylate mofetil

Filgrastim provided as needed for neutrophil support

Filgrastim

Granisetron administered as an anti-nausea agent (anti-emetic) at 1 mg orally 30 to 60 minutes before TLI

Solumedrol, an anti-inflammatory glucocorticoid containing methylprednisolone sodium succinate, administered at 1 mg/kg as a premedication for anti-thymoglobulin (ATG)

Solumedrol

Acetaminophen administered orally at 650 mg 1 hour prior to infusion of PBPC

Diphenhydramine administered by intravenous infusion at 50 mg 1 hour prior to infusion of PBPC

Hydrocortisone administered by intravenous infusion at 100 mg 1 hour prior to infusion of PBPC

David Miklos

To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)

To test if prophylactic anti-B-cell therapy (weekly rituximab) given within 60 to 90 days after allogeneic transplantation will decrease allogeneic donor B-cell immunity and possibly the incidence of chronic graft-vs-host disease (cGvHD).

Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD

An Open-label, Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft Versus Host Disease After TLI/ARG Nonmyeloablative Allogeneic Stem Cell Transplantation

The cumulative percentage of participants who develop chronic graft-vs-host disease (cGvHD). Chronic cGvHD was defined as at least one instance of a clinically-accepted marker for cGvHD (see Filipovich, et al. Biology of Blood and Marrow Transplantation. 2005;11:945-955)

Subjects who Relapsed following after Allogeneic HSCT

Number of participants who died within 100 days and within 1 year, non-relapse and associated with relapse.

The Leukemia and Lymphoma Society

National Cancer Institute (NCI)

Stanford University

Assistant Professor of Medicine

Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab

Prophylactic Rituximab

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

CLL- Chronic Lymphocytic Leukemia

MCL- Mantle Cell lymphoma

unknown or Not Reported

Patient Disease characteristics

David Miklos, MD, PhD; Associate Professor of Medicine (Blood and Marrow Transplantation)

35 total participants were analyzed. No data is available for the withdrawn participant.

Chronic Graft-vs-Host Disease (cGvHD)

Incidence of Relapse

Mortality within 100 days, all causes

Nonrelapse mortality within 1 year

Relapse + mortality within 1 year

Mortality

CLL participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab

Prophylactic Rituximab (CLL Patients)

MCL participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab

Prophylactic Rituximab (MCL Patients)

Overall Survival

Overall Study

Spots Global Cancer Trial Database for Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial